Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts. The Food and Drug Administration (FDA) describes that generic drugs are essential possibilities that allow better access to healthcare for all Americans. They are replicas of brand-name drugs and are the identical as those of brand-name drugs in dosage form, safety, strength, route of administration, quality, performance features, and anticipated to use. Healthcare authorities and users can be guaranteed that FDA-approved generic drug products have met the same stiff principles as the innovator drug. The company that made Bayer aspirin fought in court enthusiastically to keep generic versions off the shelves, in the 1920s. The company lost in court, and consumers suddenly had an array of choices in generic aspirin. The Supreme Court of India uttering ‘the Supreme Court's ruling will prevent companies from further seeking unwarranted patents on HIV and other essential medicines.’ Generic medicine cannot be sold at a price higher than the branded medicine, so it is regularly a low-priced option. Thereafter, both the end user and the government who pay for part of the price of the medicine under the Pharmaceutical Benefits Scheme in Australia are benefitted. The treatment of diseases using essential drugs, prescribed by their generic names, has been emphasised by the WHO and many national health policies. Although there are some improvements in generic medicine prescribing, it has been advised by the WHO that ‘countries should intensify efforts to measure and regularly monitor medicine prices and availability, and adopt policy measures to address the issues identified.’

‘Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts'.[1] The Food and Drug Administration (FDA) of the USA requires generic drugs to have the same quality and performance as brand-name drugs. Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product.[2] The FDA requires that all drugs should be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.[3] The FDA describes that generic drugs are essential possibilities that allow better access to healthcare for all Americans. They are replicas of brand-name drugs and are the identical as those brand-name drugs in dosage form, safety, strength, route of administration, quality, performance features, and anticipated to use. Healthcare authorities and users can be guaranteed that FDA-approved generic drug products have met the same stiff principles as the innovator drugs. All generic drugs permitted by the FDA have the same high quality, strength, purity, and stability as brand-name drugs. The generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs.[4]

Generic Medicine and Court Verdicts

The company that made Bayer aspirin fought in court enthusiastically to keep generic versions off the shelves, in the 1920s. ‘The company lost in court, and consumers suddenly had an array of choices in generic aspirin'.[5] ‘The Supreme Court ruled on Monday that generic drug manufacturers could not be sued by patients who claim that drugs they took were defectively designed. The decision is a significant victory for the generic drug industry, but further narrows the recourse for people who are injured by such drugs'.[6] The Indian Supreme Court supported a portion of India's patent law critical to conserving the nation's generic drug industry when it ruled that the Swiss pharmaceutical company Novartis should not receive a patent for its leukemia drug Gleevec®. This verdict was being supported by one consumer group and congratulate the Supreme Court of India uttering ‘the Supreme Court's ruling will prevent companies from further seeking unwarranted patents on HIV and other essential medicines'.[7] The U.S. Supreme Court has refused to re-assess a case that emphasised the combative concern of ‘product labelling and the extent to which generic drug makers are able to independently and quickly act to provide consumers with risk information'.[8]

Advantages of Generic Medicine

Costlier propitiatory medicines can now and again upset people's financial capability to rigorously stick to the dosage schedule prescribed by the doctor, especially when there are many repeats and the medicine has to be procured on multiple times. The foremost benefit of generic medicine use is the cost-efficacy benefit. Generic medicine cannot be sold at a price higher than the branded medicine, so it is regularly a low-priced option. Thereafter, both for the end user and the government who pay for part of the price of the medicine under the Pharmaceutical Benefits Scheme in Australia are benefitted. Hence, patients can adhere their medications as prescribed by the doctor.[9] As soon as a pharmaceutical industry designs and develops a new drug, it gains a patent for that drug. The patent safeguards the developer's investment in developing the drug, and no one else can lawfully vend the meticulously same drug for a period up to 17 years. That patent-protected drug is the innovator drug. Therefore, when patients, hospitals, communities, or government purchase that particular medicine actually paying for the ‘research costs, the costs incurred in proving it is safe, the costs to market and transport the drug, and a premium if it is the only available drug for a certain symptom, disease or condition'.[10] Those costs can patent drugs very expensive to purchase by patients or government at many occasion. The industry thinks that the price is the way to recover its development overhead expenditures. The moment that patent-protected time has expired, any other company can produce and market that drug with the same ingredients as the branded one. Nonetheless, the FDA ensures that the product will be exactly ‘identical, or bioequivalent, to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance, characteristics, and intended use’[11] and also asserts that a generic drug must be given a new name. Since the company that manufactures the generics did not incur the costs of the original research, testing, or marketing, the cost is lower'.[10] Another study reported that the principal advantage of low cost of generic medicine is that it saves as high 90% over the cost of brand medicine. Generics on an average save 40%–60% than proprietary medicine. That is a real plus point especially for geriatric population on a fixed income who take numerous medications.[12] In a systematic meta-analysis which includes 47 studies (38 of 47 were randomised controlled trials) covering nine subclasses of cardiovascular medications (beta-blockers, diuretics, calcium channel blockers, antiplatelet agents, statins, angiotensin-converting enzyme inhibitors, and alpha-blockers), no evidence of superiority regarding efficacy and safety of brand-name drugs versus generics was found. Even with those having narrow therapeutic index drugs such as antiarrhythmic agents and warfarin show 100% clinical equivalence.[13] Many people in both developing and developed countries apprehend that generic medicines are somehow inferior in quality, but essentially this is not true. Unlike generics, any other products, such as cereal, soap, or canned goods, where the brand is indeed claimed better, are not applicable for generics. As generic medicines are exactly same molecule and produced following the identical procedures like that of branded-proprietary medicine. Thereafter, generic medicines obtain approval from the FDA, or any other drug regulatory authority rules require generic drugs to have the same active chemicals as the original brands.[14]

Generic Medicine and Low-income Countries

Medicines account for 20%–60% of global health expenses, somewhat more in low- and middle-income countries, and therefore, constitute a most important part of the budget[15],[16] and 18% in countries of the Organization for Economic Co-operation and Development.[16] Up to 90% of the people in developing countries consume medicines through out-of-pocket payments,[17] making medicines the major family-spending item after food. Thus, medicines are unaffordable for large sections of the global population and are a major burden on government budgets.[16] The Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, completed in 1994, transformed global patent law by necessitating the standardisation of intellectual property law among all WTO member countries by early 2005. Instantaneously, there raises apprehension that the TRIPS agreement would minimize public health facilities in low- and middle-income countries.[18] TRIPS threats to the supply of generic antiretroviral medicines from ‘India are coming at a time when the prospects of antiretroviral therapy scale up are already cloudy'.[19] Thereafter, the provision of generic medicine is one of the best operational means of bringing lifesaving therapeutics and vaccines to the low-income countries and marginalised communities throughout world (Editorial).[20]

Generic Medicine Promotes Rational Prescribing

The treatment of diseases using essential drugs, prescribed by their generic names, has been emphasised by the WHO and the National Health Policy of India.[21],[22] Code of Ethics Regulations 1.5, 2002 of Medical Council of India describes the uses of generic names of drugs: ‘Every physician should, as far as possible, prescribe drugs with generic names and he/she shall ensure that there is a rational prescription and use of drugs'.[23] Therefore, to promote rational prescribing, it has been resolutely advocated to use the generic name, for example, omeprazole instead of zegerid. Thereafter, prescriber does not express any inclination towards any particular proprietary brand of the drug.[24] Against the background of such strong law, the actual scenario was something very deplorable. It was found that the prescription of generic drugs ranged from 3% to 20%.[25] Another study conducted in Delhi, India, found generic prescribing in outpatient department to be 6.32%–25.14% which was quite similar with an earlier study.[26] After few years, one more additional study in a major teaching tertiary-level public hospital found that there was quite higher (73.4%) generic prescribing.[27] The drug prescribed by generic name was 48.5% in overall situation in Madhya Pradesh, India. Medicines prescribed by generic name in primary health centres (PHCs) were higher as compared to civil dispensaries (CDs) which were statistically significantly higher (P < 0.001). The drugs prescribed from Essential Drug List (EDL) of Madhya Pradesh (India) were 66.9%. Yet again, PHCs were prescribing is statistically significantly (P < 0.001) higher in number from EDL as compared to CDs.[28]

One multicentre study in eight cities of South and Midwest of Brazil reported that most drugs (86.1%) were prescribed by generic name.[29] Nonetheless, irrespective of the level of healthcare delivery system, prescribing drugs by generic name reduces duplicity, improves access to medicines, and subsequently, escalates patient compliance with drug therapy and disease control. It is expected that emphasizing to medical students about generic medicines will improve and promote rational prescribing.[29] The percentage of generic prescribing was 100% in all four hospitals of United Arab Emirates as recommended by the WHO. The success of generic prescribing was because of electronic prescribing systems in healthcare services.[30] One Cambodian study conducted in three health centres reported that prescribing by generic names was 99.8%. It was really encouraging against the background of reducing the irrational use of drugs at the health centre level which remains a major challenge.[31] Although many other issues of rational prescribing and healthcare still exist in Cambodia, the percentage of drugs prescribed by generic name and from an essential drug list in Hawassa University Teaching and Referral Hospital of Ethiopia was 98.7% (n = 2419) and 96.6% (n = 2367), respectively.[32] Although, earlier study findings were 75.2% and 87% in Jimma Hospital and National baseline study of Ethiopia, respectively.[33],[34] Generic prescribing was found to be 49.3% in Nigerian army hospitals.[35] In another Nigerian study in a tertiary care teaching hospital, generic prescribing was found similarly low at 42.7%.[36] The drugs prescribed by generic name was 64.12%, and from the National Essential Drug List was 67.70% in village health clinics across ten provinces of western China.[37] Prescribing generic names in three public hospitals, namely, Pakistan Institute of Medical Sciences Islamabad, Rawalpindi General Hospital and Military Hospital of Rawalpindi, found quite low (23.6%) but 80% of medicines prescribed were from the National EDL Drug List of Pakistan.[38] Although there were improvement regarding generic prescribing and utilization of EDL but the country need lot more to do to improve rational prescribing and to ensure better health care.

Physician Perception Regarding Generic Medicines

Largely, the mainstream of physicians is comfortable with the efficacy of generic medications and is satisfied in using generics. Nonetheless, there are significant fractions of physicians’ expresses their apprehensions about the efficacy and quality generics, and especially senior physicians have definite trepidations.[39] A systematic review analyzing 52 articles revealed that a noteworthy number of doctors were concerned about the efficacy, safety, and quality of generic medicines. Moreover, doctors believe that generic medicine causes more adverse effects. The negative perceptions of specially among doctors and pharmacists are the principal obstacles for wider acceptance of generic medicines both in individual and community level.[40] One recent Greek study reported that the national initiative for generic prescribing has been poorly endorsed by the physicians of the country.[41] Nevertheless, Jordanian physicians have a positive attitude in the direction of generic medications and highly motivated to prescribe generic medicines.[42]

Medical Students’ Perception Regarding Generic Medicines

Although other aspects of generic medicines knowledge level were found good, there was a significant knowledge gap about the regulatory bioequivalence limits for generic medicines.[43] Medical and pharmacy students of Bangladesh possess a moderate knowledge level of generic medicines. Moreover, it has been found that pharmacy students were more inclined about generic medicines than that of medical students. The study finally recommended that Bangladeshi medical educational authorities should take abrupt action to transform curricula to safeguard better understanding of future medical practitioners about the use of generic medicine.[44] Another Afghan study reported that medical students need more accentuates to improve awareness and knowledge about generic medicines. There is an urgent need to progress regarding the knowledge level of the quality, prices, and safety of generic medicines including cost-efficacy.[45] Another study from Iraq clearly shows that medical students in Iraq are deficient related to generic medicine use. The study thereafter suggested that incorporation of generic medicine use in curriculum may improve and promote the use of generic medicines and prescribing.[46] The principal result of one study from the USA was that only 24% of study participants possess proper knowledge of generic medicines. Therefore, promoting the use of generic medicines and prescribing is imperative to minimize healthcare costs.[47] The overall perception of medical students regarding generic medicines is not up to the mark to promote generic prescribing. Therefore, there is an urgent need to enhance medical students’ knowledge and attitude in their teaching–learning sessions of clinical pharmacology regarding generic medicines and promoting generic prescribing. Hence, community or country can minimize healthcare costs and also ensure rational prescribing.

Generic Medicines and Neglected Diseases

A lot of diseases conquer because drugs are old and ineffective, or merely do not exist. Every year, 1 billion people globally are affected by neglected diseases, such as malaria, tuberculosis (TB), leishmaniasis, and lymphatic filariasis, which impose tremendous public health burdens.[48] TB is a major killer in poor countries, but no new anti-TB drug has been developed since the 1960s.[49] There are rare, often life-threatening diseases, defined in Europe as affecting fewer than one in 2000 people, for which more ‘orphan drugs’ need to be developed.[50],[51] There are diseases that are highly prevalent, such as HIV/AIDS in South Africa, but while new, effective medicines exist, millions of people and their governments cannot afford them or they are not available at all.[52],[53] Neglected tropical diseases, such as malaria, affect millions of people, but most are too poor to constitute a market that is profitable enough in the private market to develop new treatments.[54],[55] Since the 1970s, some pharmaceutical industries in developing countries have been unfolding new production procedures through reverse engineering technology to produce medicines which are still under patent elsewhere in the world.[56] This generic production has contributed to both industrial development and greater access to medicines through lower prices.[56] These countries may not be able to continue to produce generic medicine as because of the introduction of new stronger and stringent patent protection law.[57] Currently, the principal approach for safeguarding access to medicines for neglected diseases is drug donation from Western drug industries.[58] Nevertheless, this reliance upon profit-driven organisations is dangerous. Undoubtedly, a more defensible approach is required.[58] Public, private, and benevolent societies and groups internationally have started to work together to find and produce new medicines to treat neglected diseases.[59],[60],[61]

Generic Medicines and Essential Drugs

‘Essential medicines are those that satisfy the priority healthcare needs of the population. Essential medicines are selected with due regard to disease prevalence and public health relevance, evidence of clinical efficacy and safety, and comparative costs and cost-effectiveness. Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford. The model list is a guide for the development of national and institutional essential medicine lists. It was not designed as a global standard. However, for the past 30 years, the model list has led to a global acceptance of the concept of essential medicines as a powerful means to promote health equity. Most countries have national lists and some have provincial or state lists as well. National lists of essential medicines usually relate closely to national guidelines for clinical healthcare practice which are used for the training and supervision of health workers'.[62] ‘The WHO Model Lists of Essential Medicines has been updated every 2 years since 1977. The current versions are the 19th WHO Essential Medicines List and the 5th WHO Essential Medicines List for Children updated in April 2015'.[63] ‘In 1977, nearly a dozen countries had what would now be considered an essential medicines list or an essential drugs program. Today, four out of five countries – at least 156 countries in total – have adopted national essential medicine lists. Thirty years ago, the concept of a national drug policy was unknown to most countries. Today, over 100 countries have such policies in place or under development. In 1977, objective information on the rational use of medicines was extremely limited, especially in developing countries. Today, at least 135 countries have their own therapeutic manuals and formularies, which provide health professionals with up-to-date, accurate, and unbiased advice on the rational use of drugs. When the first Essential Medicines List appeared, the WHO Programme for International Drug Monitoring was just being formally established. Today, a network of 83 countries provide global monitoring for adverse drug reactions and regularly pick up signals on potential safety problems. Thirty years ago, there was virtually no publicly available price information and few countries actively encouraged generic substitution. Today, at least 33 countries have carried out availability and pricing surveys and provide that information publicly. In addition, the wider use of quality-assured generic medicines since the 1990s has brought down prices through increased demand and competition'.[64]

The high price of medicines, predominantly in the private sector, is additional strategic hurdle to access to inexpensive essential medicines in developing countries.[65] Several countries have made considerable improvement towards increasing access to essential medicines and treatments to combat HIV/AIDS, malaria, and TB, but access to essential medicines in developing countries is not sufficient. In countries for which there is information, the availability of medicines in the public sector is only one third, while private sector availability is about two thirds, and the prices people pay for low-priced generic medicines vary from 2.5 times to 6.5 times international reference prices in these two sectors, respectively.[65] ‘Access is defined as having medicines continuously available and affordable at public or private health facilities or medicine outlets that are within one hour's walk from the homes of the population'.[66] In the mainstream of circumstances, generically equivalent medicines are priced substantively lower than the originator brand.[67] Increasing the use of quality-assured generic medicines is, therefore, a key strategy for improving the affordability of medicine. A range of policy options is available to promote the use of generics, including allowing pharmacists to dispense a generically equivalent product in place of the originator brand listed on the prescription. Such generic substitution by pharmacists is allowed in many countries, sometimes with a requirement to inform the patient.[68] Lawful provisions to permit will inspire much more generic changeover of medicine from costly branded proprietaries in the private sector which occurs in 86% and 100% of the developed and transition economies, respectively.[69],[70],[71] The WHO suggested that to accelerate the progress of essential medicines many policy changes needed both at national and global level needed. Those are ‘At the national level: (i) eliminate taxes and duties on essential medicines; (ii) update national policy on medicines; (iii) update the national list of essential medicines; (iv) adopt generic substitution policies for essential medicines; (v) seek ways to reduce trade and distribution markups on prices of essential medicines; (vi) ensure adequate availability of essential medicines in public healthcare facilities; (vii) regularly monitor medicine prices and availability. At the global level: (i) encourage pharmaceutical companies to apply differential pricing practices to reduce prices of essential medicines in developing countries where generic equivalents are not available; (ii) enhance the promotion of the production of generic medicines and remove barriers to uptake; (iii) increase funding for research and development in areas of medicines relevant to developing countries, including children's dosage forms and most neglected diseases'.[65]

Generic Medicines’ Situation in Malaysia

One study conducted in Malaysia reported that practically half of the respondents had negative belief in generic medicines. Correspondingly, many patients were not conscious of the relationships and variances between generic and original brand medicines. Consequently, there is a need to provide patients with adequate information about generic medicines.[72] Although the Government of Malaysia has definite policy regarding generic medicines to foster healthy competition in medicines pricing, the generic shall be ‘used to guide the use and procurement of medicines as follows: (1) prescribing in generic International Non-proprietary Name (INN) shall be practiced at all channels; (2) procurement of all medicines by generic INN shall be promoted; (3) in selection for procurement, priority shall be given to domestically manufactured medicines; (4) all dispensed medicines shall be labeled prominently with the generic INN of the medicine with or without the brand-name; (5) a list of interchangeable and noninterchangeable medicines shall be made available; (6) generic substitution shall be permitted and legislated for all interchangeable medicines; (7) appropriate incentives to promote the use of generic medicines and their production in the country shall be introduced'.[73] Nevertheless, another study revealed the lack of awareness about the regulatory approval system of generic medicines. Furthermore, negative insights about safety, quality, and efficacy of generic medicines persist among different healthcare different stakeholders in Malaysia. In addition, there was a gap between policy construction and its execution in Malaysia.[74] Malaysia's well-established public healthcare system is encountering new threat from increasing medicine costs. The free market by definition does not control prices of any product including medicine, demanding price monitoring, and control mechanisms. Markups for generic products are greater than for innovator brands. Reducing the base price without controlling markups maximizes profits for retailers and dispensing doctors without plummeting the price paid by patients. Promotion of generic medicines, and improved accessibility of medicines in the public sector are required to increase access and affordability of most essential medicines for the common people of Malaysia.[75] Thereafter, the aims of National Medicine Policy of Malaysia[73] which describe access to affordable and lower priced medicines for common people of Malaysia are not being achieved.[75]

Struggle of Bangladesh for Generic Medicines

The Bangladesh court ordered that ‘doctors must use generic drug names rather than specifying particular brands'.[76] Bangladesh has built a durable baseline and self-sufficient medicine production line after the promulgation of Drug Control Ordinance – 1982. Such development of pharmaceutical sector has contributed substantially to its economy and developed from an import-dependent country to self-reliant and exporting globally. Bangladeshi pharmaceutical industries have started to produce vaccine, insulin, anticancer drugs, etc. Pharmaceutical industries are quite successful in domestic market. Hence, the pharmaceutical sector has already been acknowledged as the thrust sector by the Government of the People's Republic of Bangladesh.[77],[78],[79] In South Asia, India is the principal producer of generic drugs followed by Bangladesh and Sri Lanka.[80] The Bangladesh pharmaceutical industry produces about 8000 generic drugs under 26,813 registered brands in different dosages and strengths. The Government of Bangladesh controls the price of 209 generic drugs in specified dosage forms, along with 41 active pharmaceutical ingredients produced in the country and medicine imports. Bangladesh exports about 500 pharmaceutical items, including active pharmaceutical ingredients as well as a wide range of pharmaceutical products covering all major therapeutic classes and dosage forms, to about 100 countries.[81] Bangladesh is targeting to progress thirty world-class pharmaceutical industries in the next decade to establish a strong position in the international medicine markets. Bangladesh country is exempted from obligations to implement patents and data protection for pharmaceutical products until 2033 as a least developed country.[81] Thereafter, Bangladesh is allowable to manufacture any patented medicines without taking prior consent from innovator.[79] Finally, it has been reported that ‘medicine price in Bangladesh is currently among the lowest in the world'.[79]

Conclusion

The WHO says ‘medicine availability and prices in both public and private sectors are key indicators of access to treatment. Public sector accessibility of generic medicines is <60% across the WHO regions. Again, due to the low availability of medicines in the public sector, patients are often forced to purchase medicines in the private sector'.[82] Although there are some improvement in generic medicine prescribing, it has been advised by the WHO that ‘countries should intensify efforts to measure and regularly monitor medicine prices and availability and adopt policy measures to address the issues identified'.[82]

Desalegn AA. Assessment of drug use pattern using WHO prescribing indicators at Hawassa University Teaching and Referral Hospital, south Ethiopia: A cross-sectional study. BMC Health Serv Res 2013;13:170.